Data Collection, Storage, & Access

The written data on the paper files will be kept in a locked file cabinet
at Sunny Hill Health Centre for Children. The de-identified data from the
different provincial sites will be uploaded into the Canadian Cerebral Palsy
Registry using a code to ensure privacy of data, in accordance with the research
protocol. Specifically, all of the data collected regionally will be entered in
the electronic data bank using REDCap, specialized software designed for medical
data collection and distributed by Vanderbilt University. REDCap is web based
and uses 128 bit data encryption and provides role based security requiring a
user ID and password for access.

The central databank is located in Edmonton at the
University of Alberta Hospital and the data collection system will be housed on
servers provided by the Women & Children’s Health Research Institute in
Edmonton. The servers are located in a secure data centre in the basement of
Edmonton’s University Hospital. Data integrity is protected by multiple
redundant power and cooling systems, RAID disk technology and regular back-up to
tape.

The Women & Children’s Health Research
Institute (WCHRI) in Edmonton in collaboration with the Neuroinformatics core of
NeuroDevNet at UBC will be responsible for the day to day operations of the
database, inclusive of IT support. Dr Andersen, a co-investigator from the
University of Alberta, the WCHRI and the Neuroinformatics core will ensure that
the CP data is used responsibly and respectfully and that privacy is
safeguarded. This includes ensuring only agreed personnel have access to the
information held in the Canadian Cerebral Palsy Registry.

The WCHRI of the University of Alberta agrees to
hold in confidence all of the data received from the different centers across
Canada. The data uploaded to the Canadian Cerebral Palsy Registry will not
contain any personal identifying information. All of the parties contributing
data to the Registry will adhere to and comply with applicable laws and
regulations regarding protection of personal information.

The Canadian Cerebral
Palsy Registry will operate for as long as the research team can ensure its
proper management, as stipulated by the Canadian Institute of Health Research
and by Health Canada. Presently, the Canadian Cerebral Palsy Registry is funded
by the NeuroDevNet Networks of Centres of Excellence and by the Public Health
Agency of Canada and will continue to operate for as long as funding is
available. In the event that funding is not renewed and that no other funding is
secured, the de-identified data will be conserved on an Encrypted Digital
storage device and given to the lead researcher, Dr Michael Shevell, for safe
keeping. The data from the individual participating sites will be stored on
separate Encrypted Digital storage devices and returned to the persons
responsible at each site. The data on the Encrypted Digital storage devices
given to the individual participating sites and to the lead researcher could be
migrated into a new database if new funding would become available.

Governance

Management of the
Registry:

Dr Michael Shevell, the lead investigator
overseeing the Canadian Cerebral Palsy Registry, shall be responsible for all
aspects of the management of the Canadian Cerebral Palsy Registry. All of the
parties contributing data to the registry shall exercise due care in complying
with the principles of Good Clinical Practice as reflected in the ICH-GCP
Guidelines (1996) and will abide by CIHR guidelines governing research involving
human subjects. All parties will observe the methodology described in the
Research Protocol, when collecting the data for the registry. Any changes to the
study protocol must obtain prior written approval from the lead
investigator.

The target enrolment for the different
participating institutions in the Canadian Cerebral Palsy Registry has been
described in the Research Protocol. The parties agree to try to recruit the
projected number of study subjects, although a higher number of study subjects
may also be recruited.

The Co-Investigators in the different provinces
shall prepare and maintain accurate and complete records of the work performed
in connection with the Canadian Cerebral Palsy Registry, in accordance with
generally accepted research practices.

Provisions to Ensure Security and
confidentiality:

The de-identified data from the different provinces
will be uploaded into the Canadian Cerebral Palsy Registry using a code to
ensure privacy of data, in accordance with the research protocol. Specifically,
all of the data collected regionally will be entered in the electronic data bank
using RedCap, a specialized software designed for medical data collection and
distributed by Vanderbilt University. RedCap is web based and uses 128 bit data
encryption and provides role based security requiring a user ID and password for
access. The central databank is located in Edmonton at the University of Alberta
Hospital and the data collection system will be housed on servers provided by
the Women & Children’s Health Research Institute (WCHRI) in Edmonton. The
servers are located in a secure data centre in the basement of Edmonton’s
University Hospital. Data integrity is protected by multiple redundant power and
cooling systems, RAID disk technology and regular back-up to tape. The Women
& Children’s Health Research Institute in Edmonton in collaboration with the
Neuroinformatics core of NeuroDevNet at UBC, will be responsible for the day to
day operations of the database, inclusive of IT support. Dr Andersen, the WCHRI
and the Neuroinformatics core will ensure that the CP data is used responsibly
and respectfully and that privacy is safeguarded. This includes ensuring only
agreed personnel have access to the information held in the Canadian Cerebral
Palsy Registry. These individuals are named in Appendix A, attached hereto.
These names may be modified from time to time by mutual agreement of the
parties.

Outside researchers may obtain access to the
de-identified data but only with permission from the Canadian Cerebral Palsy
Registry Policy and Research Group and the University of Alberta ethics
committee. The WCHRI of the University of Alberta agrees to hold in confidence
all of the data received from the different centers across Canada. The data
uploaded to the Canadian Cerebral Palsy Registry will not contain any personal
identifying information. All of the parties contributing data to the Registry
will adhere to and comply with applicable laws and regulations regarding
protection of personal information.

Ownwership and Data
Utilization:

Each center entering data into the national
registry is regarded as an independent contributor of the CP data and retains
all rights to their data. The data generated at each center shall remain at all
times the property of each individual contributing institution. The data entered
into the Canadian Cerebral Palsy Registry shall only be used for scientific
purposes and shall not be used, directly or indirectly, for commercial
purposes.

Procedures to follow for participants
who wish to withdraw their data:

Participants can withdraw at any point. In the
event that a parent would like to withdrawdata from the central data bank, he or
she would contact the site study coordinator who would then retrieve the child's
code, used to enter de-identified data in the electroniccentral data bank. This
code will be linked to the child's personal data and the personal data will only
be accessible to the on-site study coordinator, where the child will have been
registered. The on-site study coordinator will then contact the people
responsible for the data bank at the University of Alberta providing them with
the child's de-identifying code, requesting that they destroy the data
associated with this code.

Provisions in the Event of the Termination
of the Registry:

Presently, the Canadian Cerebral Palsy Registry is
funded by the NeuroDevNet Networks of Centres of Excellence and will continue to
operate for as long as the research team can ensure its proper management. In
the event that funding is not renewed and that no other funding is secured, the
de-identified data will be conserved on an Encrypted Digital storage device and
given to the lead researcher, Dr Michael Shevell, for safe keeping. The data
from the individual participating sites will be stored on separate Encrypted
Digital storage devices and returned to the persons responsible at each site.
The data on the Encrypted Digital storage devices given to the individual
participating sites and to the lead researcher could be migrated into a new
database if new funding would become available.

Publications:Any
researcher with published articles making reference to the data or using the
data from the Canadian Cerebral Palsy Registry, will acknowledge the Registry,
NeuroDevNet and the Public Health Agency of Canada, and will give credit to the
Canadian Cerebral Palsy Registry researchers as scientifically appropriate,
based on any direct contribution they may have made to the work.

Canadian Cerebral Palsy Registry Policy
and Research Group:

Individuals from each of the provinces contributing
data to the Registry or providing support to the Registry, will be appointed to
the Canadian Cerebral Palsy Registry Policy and Research Group. The role of the
Canadian Cerebral Palsy Registry Policy and Research Group will be:

1. To provide strategic direction on the ongoing development of the
Canadian Cerebral Palsy Registry. The focus of the strategic direction will
mainly deal with the following subjects:

The inclusion criteria for registrations into the Canadian
Cerebral Palsy Registry

Ascertainment procedures for registration

Reporting and disseminating information contained within the
Canadian Cerebral Palsy Registry

Collaboration with other registries and databanks

Determination of the direction of research and use of the
Canadian Cerebral Palsy Registry data

Development of a research policy to ensure that issues of
intellectual property pertaining to the Canadian Cerebral Palsy Registry are
appropriately managed and that the Canadian Cerebral Palsy Registry is
acknowledged appropriately

2. To facilitate research projects in this
field by:

Reviewing and considering all research
applications submitted;

Approving all research proposals
prior to obtaining ethical approval;

Maintaining appropriate
records of all proposed research projects;

Referring projects
to the relevant Ethics Committee(s) for approval.

The members of the Canadian Cerebral Palsy
Registry and Research Group will abide by the following governance charter
guidelines

Good governance is essential to maintaining trust between members

Members should feel free to ask searching and revealing question

At all times, members will act to promote the values and attitudes that
reflect accountability, professionalism and personal responsibility and members
will act in the interests of the CP community

Members will not take improper advantage of their involvement in the
Canadian Cerebral Palsy Registry or improperly disclose information
exchanged between members and will disclose any conflicts of interest, perceived
or otherwise, for resolution

Members should demonstrate an enthusiasm, interest and energy that
contribute to the ongoing success of the Canadian Cerebral Palsy Registry
andthe achievement of its goals

Members will ensure that issues of intellectual property pertaining to the
Canadian Cerebral Palsy Registry are appropriately managed in line with
the guidelines provided by the International Committee of Medical Journal
Editors http://www.icmje.org#author

Members to the Registry

The following individuals will have access to the data contained in the Canadian Cerebral Palsy Registry:

Members of the University of Alberta ethics committee; members of other ethics committees involved in the project

The provincial project coordinators will have access to the data from their respective sites.

Any other lead researcher who joins the registry will also be granted access to the data. Outside researchers may obtain access to the de-identified data but only with permission from the lead researchers and the University of Alberta ethics committee.

Funding for this publication was provided by the Public Health Agency of Canada. The opinions expressed in this publication are those of the authors/researchers and do not necessarily reflect the official views of the Public Health Agency of Canada.

How do I register my child?

If you have a child who has a diagnosis of cerebral palsy
(CP) and who was born after January 1, 2009, you can register in a number of
ways:

Give permission for your physician or
health care professional to send your contact information to the project
coordinator so that you can receive more detailed information in
person

Contact the project coordinator directly so that you can receive more detailed information in
person

If your child is identified as a candidate for the
CP Registry and you receive a letter from the principal investigator with more
information about the registry you can discuss further with the project
coordinator once you are contacted

When you meet the project coordinator, you will have
the option of participating in the registry. The project coordinator will review
a “consent to participate” form that will explain the registry in detail. The
coordinator will answer any questions you might have about the study. If you are
unable to meet in person with the coordinator, the consent form can also be
explained over the phone and mailed to you. At this point you are completely
free to participate in the registry or refuse to participate. Your child’s
medical care and his or her relationship with the physician concerned as well as
with any other professionals will not be affected in any way.

Who is eligible to register?

All children with a diagnosis of CP born in 2009 or later
and who reside in Canada are eligible to be registered in the CP Registry after
the age of 2. The inclusion of age of 2 has been chosen as the diagnosis of CP
is often difficult to confirm prior to this age. Children with CP born prior to
2009 will be excluded from the registry as 2009 has been chosen as the starting
point in BC.

Why do we need a CP Registry?

Cerebral palsy is a disorder of movement and posture
resulting from damage to the developing brain. It is the most common cause of
physical disability in children in Canada. We want to better understand the
causes of CP in BC and across Canada. We also want to know how often children
are being diagnosed with CP and where they live in the different regions of BC
and across the different provinces of Canada. By looking at this information
across different regions, we might be able to find risk factors and understand
more about the causes of CP. The CP Registry will provide a coordinated data
collection system in Canada to increase the scope of research into CP and
improve the quality of research by providing access to a large population
sample.

Can I change my mind about participating in the registry?

Yes.Your participation in the CP Registry is voluntary.
You will be asked to provide written consent to have your information included
into the registry. You may also withdraw at any point. If you would like to
withdraw your child’s information, contact the BC project coordinator who
will remove your child’s non-identified information from the central web-based
databank. At the local site, any paper copies will also be destroyed. Withdrawal
from the registry will not disadvantage your child in any way or affect services
being received.

What about my privacy?

We respect your privacy. The information you provide to the
Canadian CP Registry is strictly confidential. Your personal information will
only be seen by the principal investigator and the project coordinator in BC.
The information data that will be uploaded into the Canadian CP Registry will
NOT contain any personal identifying information. Your personal or contact
details will never be provided to researchers or anyone else unless you
specifically indicate it is okay to do so.

What about published information?

When the results of the studies are published, you will be
given the option of receiving either a copy of the published manuscripts or a
lay summary of the articles prepared by the research team. You are also invited
to browse the NeuroDevNet site www.neurodevnet.ca where
research results will be posted.

Other questions?

If you have other questions, please email or phone the BC Project Coordinator.